FDA-Device2013-07-17Class I
Medtronic MiniMed Paradigm Insulin Infusion Sets The Paradigm infusion sets are intended for use with Paradigm insulin infusion pumps.
Medtronic MiniMed
Hazard
Medtronic is recalling the Medtronic MiniMed Paradigm Medtronic is recalling the Medtronic MiniMed Paradigm Insulin Infusion sets because of a potential safety issue that can occur if insulin or other fluids come in contact with the inside of Medtronic Paradigm infusion sets. Under certain conditions, the infusion set may malfunction and deliver an incorrect volume of insulin.
Sold states
Worldwide distribution: US (nationwide) distribution: Algeria, Argentina, Australia, Bahamas, Bahrain, Bermuda, Boliva, Bosnia and Herzegovina, Brazil, Canada, Chile, China, Columbia, Costa Rica, Croatia, Cyprus, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, Finland, France, French Southern Territories, Germany, Great Britain, Greece, Guatemala, Hong Kong, India, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kuwait, Latvia, Lebanon, Macedonia, Malaysia, Mexico, Morocco, Netherlands, Norway, New Zealand, Oman, Panama, Paraguay, Peru, Poland, Province of China, Taiwan, Qatar, Republic of Korea, Romania, Russia Federation, Saint Lucia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Syrian Arab Republic, Thailand, Trinidad and Tobago, Turkey, Ukraine, United Arab Emirates, Uruguay, and¿Venezuela.
Affected count
11,000,000 units
Manufactured in
18000 Devonshire St, N/A, Northridge, CA, United States
Products
Medtronic MiniMed Paradigm Insulin Infusion Sets The Paradigm infusion sets are intended for use with Paradigm insulin infusion pumps.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1668-2013Don't want to check this manually?
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